Reproducibility Study of the Packaging Efficiency on Preventing Photolytic Degradation in Sedil® (Diazepam) Tablets

Abstract

This work wasaimed for the determination reproducibility study of the packaging efficiency on preventing photolytic degradation of Sedil® (diazepam) which contained in a blister packaging with coating and which is photosensitive. The objective of this study was to determine the effect onDiazepam in various lighting conditions (control, sunlight, normal room light, 25watt & 40watt bulb). Besides,physical tests were performed for evaluation of color change, weight variation, thickness and hardness of Sedil® tablets from same batch according to the specification of USP. A very insignificant fluctuation in result was observed, with standard deviation ±0.001g, ±0.0009cm & ±0.2 kg for weight variation, thickness & hardness test respectively. The percent variation of the decreased concentration of the samples for normal lightening condition, 25 watt & 40 watt light exposure and sunlight exposure were found respectively 34.53%, 24.29%, 27.87%, and 31.66%. So it can be said that the Sedil® containing Diazepam is light sensitive, package should be opaque thus light cannot pass through the package.